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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. These problems can cause inflammation and may help cancer grow or make treatment less effective. Early research shows that fasting overnight might help improve these problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Overnight Fasting (POF) Group | Experimental | Participants in this group will begin and be asked to maintain a prolonged overnight fasting (POF) plan for the duration of the intervention, with modifications as needed in the immediate post-surgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an electronic journal (eJournal) through the University of Miami's My Wellness Research app. Participants will meet with a nutrition health coach weekly by video or phone call. Participants will also under blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessment and quality of life questionnaires. Total participation duration is about 10 weeks. |
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| Attention Control Group | Other | Participants randomly assigned to this group will receive general health coaching video or telephone calls weekly for the duration of the study (3 weeks prior to surgery to 6 weeks post-surgery). Sessions will last approximately 15-20 minutes each time. Participants will also undergo blood specimen collections, wear a blood sugar monitor and physical activity tracker, and complete various symptom assessments and quality of life questionnaires. At the end of the study, participants will receive a physical activity tracker and study notebooks. Total participation duration is about 10 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Overnight Fasting (POF) | Behavioral | Participants will be asked to not consume any calorie-containing food/drinks after 8pm and to fast at least 12 hours nightly, increasing to 14 hours gradually over the course of a week. Participants will be asked to maintain the prolonged overnight fasting (POF) for the duration of the intervention, with modifications as needed in the immediate postsurgery phase. Participants will be asked to record the fasting times (morning and evening) either on a paper journal that will be returned to research staff by mail, email, or text message, or by completing an eJournal through My Wellness Research Patients will enroll and begin the intervention 28 +/- 14 days prior to their scheduled surgery (hysterectomy) and continue for 6 weeks postsurgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment: Percentage of Participants That Consent to Participate and Meet Eligibility Criteria | Feasibility of recruitment will reported as the percentage of participants who consent to participate and meet eligibility criteria. Criterion for success: At least (≥) 50% of all eligible participants at Baseline (T0) consent to participate between both arms. | Baseline |
| Feasibility of Retention: Percentage of Participants Who Adhere to and Complete the Intervention and Data Collection at All Time Points. | Feasibility of retention will be reported as the percentage of participants who adhere to and complete the prolonged overnight fasting (POF) intervention and data collection at all time points. Criterion for success: Greater than (>) 70% of all assigned participants complete the intervention and data collection at all time points (T2). | Up to 10 weeks |
| Acceptability: Percentage of Participants Who Report Satisfaction with the Intervention. | Acceptability will be reported as the percentage of participants who report satisfaction with the prolonged overnight fasting (POF) intervention after completion. Criterion for success: Greater than (>) 80% of all assigned participants report satisfaction with the intervention at the time of study completion (T2). | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Metabolic Biomarker Levels at Post-Surgery Compared to Pre-Surgery, in the Intervention Versus Control Group | Change in metabolic biomarker levels (insulin, glucose, IGF-1, HbA1c) at post-surgery compared to pre-surgery, among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be used to analyze changes in metabolic biomarker levels. |
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Inclusion Criteria:
Women 18 years of age or older.
Able to provide consent.
Able to read/understand English, Spanish or Haitian Creole.
Have a diagnosis of Type I (low-grade) endometrial cancer at any stage, histologically confirmed prior to the start of the intervention.
Planned minimally invasive surgical treatment (laparoscopy or robotic approach to hysterectomy).
Approval to participate from treating oncologist, confirmed via email or in writing.
Eastern Cooperative Oncology Group (ECOG) Performance status grade 0-2.
Surgeries must be at one of the following institutions:
Internet access on a smart phone, tablet, or computer.
Agree to be randomly assigned to any study group.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grey E Freylersythe, BS | Contact | 305-243-9832 | g.freylersythe@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tracy E Crane, PhD, RDN | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This study uses a parallel design, where participants are randomly assigned to one of two treatment groups and remain in their designated group throughout the duration of the study: (1) Prolonged overnight fasting (POF) or (2) Attention Control. Randomization will follow a 2:1 ratio of fasting to control conditions.
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| Blood Specimen Collection | Procedure | Blood specimens will be collected from participants at baseline (T0), the day of surgery (T1), and at six weeks post-surgery (T2). |
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| Blood Sugar Monitor | Other | Participants in both groups will wear a blood sugar monitor for the duration of their participation on the study, except on the day of surgery. The monitor is worn on the participant's arm and checks the participants blood sugar every 15 minutes. |
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| Hysterectomy | Procedure | Participants in both groups will undergo planned hysterectomy for their endometrial cancer, standard of care. |
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| Baseline, about 28 Days |
| Fold Change in Concentration of Blood and Serum Metabolomics at Post-Surgery compared to Pre-Surgery in the Intervention Versus Control Group | Fold change in concentration of blood and serum metabolomics (> 450 water-soluble metabolites and 600 lipid-related metabolites) at post-surgery compared to pre-surgery will be reported among participants in both the prolonged overnight fasting (POF) intervention and attention control groups. Blood specimens collected at baseline (T0), the day of surgery (T1) will be analyzed using Mass Spectrometry (MS) or Nuclear Magnetic Resonance (NMR). Fold Change (FC) represents the ratio of the average metabolite concentration at post-surgery compared to pre-surgery. | Baseline, about 28 Days |
| Change in Quality of Life As Measured By Scores on the PROMIS-29 Questionnaire | Change in participant quality of life in both the intervention and control groups as measured by scores on the Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire will be reported. PROMIS-29 questionnaire is a 29-item validated measure with seven domains of health, including physical function, anxiety, depression, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities and pain intensity. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). Higher scores represent worse symptoms for symptom-oriented domains (anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance) and better health outcomes for function-oriented domains (physical functioning and ability to participate in social roles and activities). | Baseline, about 28 Days |
| Change in Quality of Life As Measured By Scores on the Rosenburg Self-Esteem Scale | Change in participant quality of life in both the intervention and control groups as measured by the Rosenburg Self-Esteem Scale will be reported. The Rosenberg Self-Esteem Scale (RSES) is a 10-item self-report questionnaire measuring global self-worth and self-acceptance. It uses a 4-point Likert scale (strongly agree to strongly disagree), with scores ranging from 0-30 (or 10-40). Scores below 15 indicate low self-esteem. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). | Baseline, about 28 Days |
| Change in Quality of Life As Measured By Scores on the Hopwood's Body Image Scale | Change in participant quality of life in both the intervention and control groups as measured by scores on the Hopwood's Body Image Scale will be reported. The Hopwood's Body Image Scale is a 10-item questionnaire used to measure affective, behavioral, and cognitive body image symptoms. Participants can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). | Baseline, about 28 Days |
| Change in Sleep Quality As Measured By Scores on the Pittsburgh Sleep Quality Index | Change in participant quality of life in both the intervention and control groups as measured by scores on the Pittsburgh Sleep Quality Index (PSQI) questionnaire will be reported. The PSQI is a self-administered questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0 to 21, with higher scores indicating worse sleep quality. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). | Baseline, about 28 Days |
| Change in Physical Activity As Measured By Scores on the Godin Leisure Time Exercise Questionnaire | Change in participant quality of life in both the intervention and control groups as measured by the Godin Leisure Time Exercise Questionnaire will be reported. The Godin Leisure Time Exercise Questionnaire assesses participants' frequency of leisure activity/exercise (strenuous, moderate or light) for more than 15 minutes during a 7-day period. Higher scores indicate a more active lifestyle. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). | Baseline, about 28 Days |
| Change in Diet Quality and Composition As Measured By Responses on the Automated Self-Administered 24 Hour (ASA-24) Dietary Assessment | Change in participant diet quality, in both the intervention and control groups, as measured by the Automated Self-Administered (ASA-24) dietary assessment questionnaire will be reported. The ASA-24 asks respondents about everything they ate and drank the previous day or in the last 24 hours. Responses collected at baseline (T0) will be compared to responses collected the day of surgery (T1). | Baseline, about 28 days |
| Change in Incidence of Symptoms Related to Chemotoxicities and Side Effects from Treatment As Measured By Scores on the PRO-CTCAE Questionnaire | Change in incidence of symptoms related to chemotoxicities and side effects from treatment among study participants on both arm as measured by scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE was developed by the National Cancer Institute (NCI) to assess symptomatic adverse events (AEs) in adult patients receiving cancer therapy. The PRO-CTCAE is a self-administered questionnaire. Scores collected at baseline (T0) will be compared to scores collected the day of surgery (T1). | Baseline, about 28 Days |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |